NuVasive 6900429Recalls & reported problems
Nuvasive, Inc. · Universal Rongeur, Pituitary Small · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517385802), received between Aug 31, 2022 and Feb 16, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2024Fracture; Fracture
THE PITUITARY RONGEUR WAS INITIALLY REPORTED TO HAVE BROKEN DURING USE IN A PROCEDURE WITH NO ADDITIONAL DETAILS PROVIDED. HOWEVER, DURING ANALYSIS OF THE DEVICE BY THE MANUFACTURER, IT WAS DETERMINED THE DEVICE EXHIBITED A FRACTURED OFF DISTAL TIP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE IN ASSOCIATION WITH THE FRACTURED OFF TIP. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18724274 ↗MalfunctionJul 24, 2023Fracture; Fracture
IT WAS REPORTED THAT WHILE CLEARING THE DISC SPACE DURING A LATERAL PROCEDURE AT L4/5, THE SURGEON NOTICED WHAT APPEARED TO BE A FRAGMENT OF METAL LEFT IN THE DISC SPACE. AFTER CHECKING THE SURGICAL INSTRUMENTS, THE SCRUB NURSE NOTICED THAT THE PITUITARY RONGEUR USED IN THE PROCEDURE WAS MISSING A PIECE OF ITS TIP. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT USING A NERVE HOOK AND ANOTHER PITUITARY RONGEUR. THERE WAS NO SIGNIFICANT DELAY OR ADVERSE IMPACT TO THE PATIENT, USER, OR SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17386198 ↗MalfunctionAug 31, 2022Fracture; Fracture
ON (B)(6) 2022 A PATIENT UNDERWENT A DISCECTOMY PROCEDURE FROM L5 TO S1. WHILE REMOVING TISSUE BETWEEN THE L5 AND S1 DISC SPACE THE SURGEON COMMENTED THE DISC SPACE WAS QUITE COLLAPSED AND THE UPPER JAW OF THE RONGEUR FRACTURED OFF WHILE ROTATING WITHIN THE DISC SPACE. THE FRACTURED PORTION WAS CONFIRMED TO BE RETRIEVED BY XRAY AND THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15329344 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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